Strength through unity

Distribution Network
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Diseases that disproportionately affect developing countries – such as malaria and tuberculosis – place pharmaceutical companies in a dilemma. To do nothing is to leave millions of people to die or suffer each year when, in theory, the means may be out there to tackle the problem. Yet the harsh reality is that people in the affected countries can rarely afford to pay for drugs – and that even hugely profitable multinationals can’t spend vast sums of money developing and distributing cures for little or no return.

That’s why GlaxoSmithKline’s work on developing vaccines and medicines through public-private partnerships looks so promising. Over the past ten years, in conjunction with governments, foundations and NGOs, GSK believes it has put together a working model that can overcome the market barriers and, in the words of Jon Pender, the company’s director of government affairs, ‘has transformed the pipeline of research and development projects for diseases of the developing world’.

GSK is not the only pharmaceutical company to have gone down this route, but it believes its extensive work on such partnerships means it’s the only business in the world now researching new vaccines and treatments for HIV/Aids, tuberculosis and malaria – the priority diseases of the World Health Organization.

The path to partnerships began when GSK joined up some years ago with WHO, the UK government’s Department for International Development, the University of Liverpool, and the London School of Hygiene and Tropical Medicine, to work on developing an anti-malarial drug therapy christened Lapdap. The work was successful; it produced a treatment that could help sufferers of a particular strain of malaria in sub-Saharan Africa. But it also established a way of working that could be carried over into other partnerships. Expenses for drug development were divided between GSK, WHO and DfiD, each paying a third, while GSK agreed to sell Lapdap at a not-for-profit price to the public sector but could price it to make a profit when selling privately. GSK covered the manpower and infrastructure expenses, but the contributions of other partners meant that the company’s investment in Lapdap was low enough to make the exercise financially viable.

Enthused by the success of that partnership, GSK has gone on to use the experience in other areas, most notably with the Medicines for Malaria Venture, which now manages 20 projects – the largest portfolio of malaria drug research in history.

In this collaboration, as is often the case in its other partnerships, the company provides the research and development plus manufacturing and distribution expertise. Academic institutions help with research, while public and voluntary sector partners such as the United States Agency for International Development and the Rockefeller Foundation help fund the development and delivery costs – and try to ensure that medicines get to the people who need them.

GSK has also created a specialist ‘drug discovery centre’ based in Tres Cantos  in Spain, which focuses  primarily on malaria and TB and prioritizes research projects according to their social and public health benefits rather than their commercial returns. It employs more than 100 scientists, half subsidized by the company’s partner organizations. Research is overseen by joint steering committees with representatives from GSK and its partners.

As medicines move into clinical development, partners contribute to the cost of running clinical trials and look at how to distribute the drugs. This reduces the cost of development for GSK and gets new products to patients faster. For instance, for one malaria product now in clinical trials, Dacart, GSK pays the internal costs of the clinical trials, such as providing the medicines for the trials and the staff to establish and oversee them, while others in the partnership pay most of the external costs, such as payments to the physicians and hospitals conducting the research. These contributions make the project workable for GSK and will enable the company to provide Dacart at a not-for-profit price to public sector purchasers, initially in sub-Saharan Africa.

A similar research and development group exists within GSK’s vaccines business, working on development of vaccines for diseases predominantly affecting the developing world. In partnership with the PATH Malaria Vaccine Initiative, GSK is making good progress on a potential malaria vaccine, with the hope that this will protect children living in sub-Saharan Africa. Thanks to $21.4million support from the Bill & Melinda Gates Foundation, GSK will be able to carry out clinical trials in Africa – with the company more than matching the external contribution it receives to defray some of the clinical development costs.

And it’s not just malaria that partnerships can tackle. GSK has also been involved in setting up the Global Alliance for TB Drug Development, another PPP, which has created the first new advance in developing an anti-tuberculosis drug since the 1960s. A separate partnership between GSK and the specially formed Aeras Global TB Vaccine Foundation, in which the Dutch Ministry of Foreign Affairs and the Danish International Development Agency are involved, is also making progress on developing a TB vaccine that has shown promising results in early-stage clinical trials. And there is work being carried out on an HIV/Aids vaccine through a partnership called the International AIDS Vaccine Initiative, in which GSK works with the Uganda Virus Research Institute and the Indian Council of Medical Research, among others.

GSK’s vice president of corporate responsibility, Julia King, believes the partnerships are a classic example of strength through unity. ‘They require flexibility, transparency and trust, but they’re a model that bring different skills and resources to a problem and enable us all to do what we could not do alone,’ she says.

Apart from the obvious plus points for the potential users of the drugs developed through these partnerships, GSK itself benefits. ‘Companies that respond sensitively and with commitment by changing their business practices to address such challenges will be the leaders of the future,’ argues Pender.

There are, inevitably, some concerns. There is heavy reliance on funding from private foundations, and GSK is urging developed world governments to become more involved so that funding sources are more diverse and therefore more secure. And partnerships have to be carefully managed with ‘clear, shared objectives’ so that everyone is singing from the same hymn sheet. It also takes time to build confidence between partners with different perspectives. But as King says, ‘this approach can work where neither pure philanthropy nor pure commerce will work’. As a result, GSK expects to be involved in more such ventures in the future.